Quantitative Ultrasound Assessment of Gastric Volume in Pregnant Women at Term
1 other identifier
interventional
60
1 country
1
Brief Summary
Solid food or fluid residue in the stomach is always a major concern when patients need medical procedures under sedation or general anesthesia, due to the high risk of pulmonary aspiration of the stomach contents. This is especially important in emergency procedures, when a fasting period is not observed. The aspiration of the stomach contents into one's lungs can lead to serious complications (such as severe respiratory failure). Information from a bedside ultrasound assessment of the stomach may be a very useful tool to decide whether or not it's safe to proceed, cancel or delay a surgical procedure. The investigotrs hypothesize that a mathematical model can be constructed to predict clear fluid volume in the stomach of non-labouring pregnant patients, as it has been developed in healthy adult volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 4, 2013
CompletedFirst Posted
Study publicly available on registry
November 8, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedMay 2, 2016
April 1, 2016
2.3 years
November 4, 2013
April 29, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Correlation between ingested volume and CSA in antrum
The patient will ingest 0, 50, 100, 200, 300 or 400mL of apple juice, and then the cross-sectional area (CSA) will be measured.
5-10 minutes
Study Arms (6)
empty stomach
NO INTERVENTIONNo fluid will be given to the patient prior to scanning.
50mL
EXPERIMENTAL50mL of water will be given to the patient prior to scanning
100mL
EXPERIMENTAL100mL of water will be given to the patient prior to scanning
200mL
EXPERIMENTAL200mL of water will be given to the patient prior to scanning
300mL
EXPERIMENTAL300mL of water will be given to the patient prior to scanning
400mL
EXPERIMENTAL400mL of water will be given to the patient prior to scanning
Interventions
Eligibility Criteria
You may qualify if:
- Volunteer non-labouring pregnant women at term (≥ 36 weeks)-
- years or older
- ASA Physical Status I-III
- kg of weight
- cm of height or taller
- Ability to understand the rationale of the study assessments and to provide signed informed consent
- Written informed consent
You may not qualify if:
- Known pre-existing abnormal anatomy of the upper gastrointestinal tract
- History of upper GI tract surgical procedure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mount Sinai Hospital
Toronto, Ontario, M5G1X5, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cristian Arzola, MD
MOUNT SINAI HOSPITAL
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 4, 2013
First Posted
November 8, 2013
Study Start
October 1, 2013
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
May 2, 2016
Record last verified: 2016-04